Job Title: Regulatory CMC Associate
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Description:
* The successful candidate will lead the management of global marketing authorization submission processes, partnering with GRA-CMC RA Scientists to create and manage Leo/Regulus submission content.
* They will provide guidance on structure and content placement within CTD registration submissions and assist with submission-related Ministry of Health responses or Lilly affiliate questions.
* Key responsibilities include triaging communications between Lilly affiliates, GRA-CMC scientists, specialists, and Quality/Reg representatives, as well as developing project management expectations across projects.
Required Skills & Qualifications:
* Bachelor's Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related scientific discipline).
* Knowledge of pharmaceutical drug development or industry-related experience is preferred.
Benefits:
* A premium workspace with flexible hybrid working options.
* Healthcare, pension, and life assurance benefits.
* Subsidized canteen, onsite gym, travel subsidies, and on-site parking.
* People Development services, Educational Assistance, and 'Live Your BEST Life' wellbeing initiatives.
Others:
* Drug development process or Industry-related experience.
* Knowledge of Agency submission procedures and practices.
* Ability to operate and manage operational requirements in a regulated environment.